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Accuracy of Bladder Scanners in Post-operative Voiding Trials

Primary Purpose

Pelvic Floor Disorders

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bladder scan post void residual
Straight catheter post void residual
Back fill voiding trial
Sponsored by
Tufts Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pelvic Floor Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Undergoing Urogynecologic surgery
  • Able to consent
  • Greater than 18 years old
  • Non pregnant

Exclusion Criteria:

  • Need for prolonged catheterization
  • Unable to consent
  • Prisoner

Sites / Locations

  • Tufts Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All subjects

Arm Description

All subjects enrolled in the study will have a back-fill voiding trial performed at the time of catheter removal after urogynecologic surgery.

Outcomes

Primary Outcome Measures

Determine if bladder scanners are accurate in determining a post void residual after urogynecologic surgery

Secondary Outcome Measures

Determine if a post void residual volume measurement is needed after a back-fill voiding trial after urogynecologic surgery

Full Information

First Posted
January 11, 2017
Last Updated
March 5, 2020
Sponsor
Tufts Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03028753
Brief Title
Accuracy of Bladder Scanners in Post-operative Voiding Trials
Official Title
Accuracy of Bladder Scanners in Post-operative Voiding Trials
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Withdrawn
Why Stopped
study coordinator left / no other current resources to complete
Study Start Date
August 2016 (undefined)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
January 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tufts Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators are trying to determine if using a bladder scanner (type of ultrasound) to check how much urine is left in the bladder is the same as checking that volume with a catheter (tube that goes into your bladder to drain urine). After urogynecologic surgery, the investigators perform a voiding trial. Water is put into the participant's bladder through the catheter (tube draining your bladder). The catheter is then removed and the participant is asked to empty their bladder. After that, the investigators will use the bladder scanner (ultrasound) to see how much urine is left in the participant's bladder. After the ultrasound, the investigators will pass a very small catheter (tube) into the bladder to take out the remaining urine. The investigators will then compare the amount obtained from the catheter to the ultrasound amount. This will also help the investigators to figure out if they need to check how much urine is left in a patient's bladder after the voiding trial.
Detailed Description
The primary aim of this study is to determine if bladder scanners are accurate in determining a post-void residual volume (PVR) after Urogynecologic surgery. The secondary aim of this study is to determine if a post-void residual volume (PVR) measurement is needed after a back-fill voiding trial on Urogynecologic post-op patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Floor Disorders

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
All subjects
Arm Type
Experimental
Arm Description
All subjects enrolled in the study will have a back-fill voiding trial performed at the time of catheter removal after urogynecologic surgery.
Intervention Type
Device
Intervention Name(s)
Bladder scan post void residual
Other Intervention Name(s)
Verathon BVI9400 Bladder scanner
Intervention Description
After voiding on the commode, all subjects will have a post void residual measured by bladder scanner
Intervention Type
Procedure
Intervention Name(s)
Straight catheter post void residual
Intervention Description
After voiding on the commode and having a post void residual measured by bladder scanner, all subjects will have a post void residual measured by straight catheter performed with usual sterile technique.
Intervention Type
Procedure
Intervention Name(s)
Back fill voiding trial
Intervention Description
Prior to catheter removal, all subjects will undergo a back fill voiding trial. The bag of the foley catheter will be removed and the subjects bladder will be filled with 300cc of normal saline (or as much as they can tolerate). The foley catheter will then be removed and the subject will be asked to void on the commode. The voided volume will be measured.
Primary Outcome Measure Information:
Title
Determine if bladder scanners are accurate in determining a post void residual after urogynecologic surgery
Time Frame
Within 48 hours after surgery
Secondary Outcome Measure Information:
Title
Determine if a post void residual volume measurement is needed after a back-fill voiding trial after urogynecologic surgery
Time Frame
Within 48 hours after surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Undergoing Urogynecologic surgery Able to consent Greater than 18 years old Non pregnant Exclusion Criteria: Need for prolonged catheterization Unable to consent Prisoner
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tanaz Ferzandi, MD
Organizational Affiliation
Tufts Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Accuracy of Bladder Scanners in Post-operative Voiding Trials

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